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FDA Clearance on Beckman Coulter’s Power Express Automated Sample Processing System

September 26, 2014 2:22 pm | by Beckman Coulter | News | Comments

Delivering on its commitment to help labs face new challenges in the ever-changing healthcare environment, Beckman Coulter has received U.S. Food and Drug Administration (FDA) 510(k) clearance on its Power Express high-speed automated sample...

MDPC Publishes Robust Security Risk Assessment Framework for Medical Devices

September 26, 2014 10:56 am | by Medical Device Privacy Consortium | News | Comments

The Medical Device Privacy Consortium's Product Security Working Group has developed a robust...

How Lack of Helium Fuels Innovation for Imaging

September 26, 2014 10:18 am | by GE Reports | News | Comments

Brigitte Prat runs Lulu’s Cuts & Toys, a popular hair salon for kids in Brooklyn’s Park...

Photos of the Day: Helium Shortage Is No Laughing Matter

September 26, 2014 10:18 am | by GE Reports | News | Comments

The U.S. is running out of helium. The shortage is no laughing matter for makers of magnetic...

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Philips to Develop Portable Ventilator to Boost Pandemic Response

September 24, 2014 11:28 am | by AAMI | News | Comments

The U.S. Department of Health and Human Services (HHS) will sponsor the development of a portable ventilator that can be stockpiled for use during pandemics or other public health emergencies. Under a three-year, $13.8 million contract...

Boston Scientific Enrolls First Patients In U.S. Trial Of The Lotus Valve System

September 24, 2014 10:42 am | by PR Newswire | News | Comments

Boston Scientific Corporation has initiated the REPRISE III clinical trial, a pivotal study to evaluate the safety and effectiveness of the Lotus Valve System in patients with severe aortic stenosis and who are considered to be at either high...

Philips to Establish Market-Leading Company in HealthTech

September 23, 2014 10:50 am | by Philips | News | Comments

At a meeting with investors and analysts in London, Royal Philips today announces the next strategic step to capitalize on fundamental market changes, by creating two market-leading companies focused on the HealthTech and Lighting solutions...

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CE Mark and European Launch of Medtronic’s TYRX Absorbable Antibacterial Envelope

September 22, 2014 10:33 am | by Medtronic | News | Comments

Medtronic, Inc. has received CE (Conformité Européenne) Mark for the TYRX Absorbable Antibacterial Envelope. This innovative mesh envelope covers an implantable cardiac device to help stabilize the device after implantation and reduce surgical...

CE Mark Grants St. Jude’s Pacing Lead Expanded Patient Access to MRI Scans

September 22, 2014 9:31 am | by The Associated Press | News | Comments

St. Jude Medical, Inc., a global medical device company, has announced CE Mark approval of updated labeling for its Tendril STS and IsoFlex Optim pacing leads, allowing existing and future patients with the devices access to magnetic resonance...

Variable Angle Locking Technology Now Available To Treat Calcaneal Fractures

September 19, 2014 3:40 pm | by DePuy Synthes | News | Comments

DePuy Synthes Companies of Johnson & Johnson launched two new variable angle plating systems featuring its proprietary variable angle locking technology. With this technology, surgeons can adapt screw trajectory to match patient anatomy and...

Ideal Cordless Ultrasonic Dissection Device for Each Patient and Procedure

September 18, 2014 10:53 am | by Covidien plc | News | Comments

Covidien plc today announced the expansion of its Sonicision Cordless Ultrasonic Dissection Device portfolio, following U.S. Food and Drug Administration 510(k) clearance of three additional device lengths: 13 cm, 26 cm, and...

Medtronic Launches New Balloon Kyphoplasty Products for Treating Spinal Fractures

September 17, 2014 9:55 am | by Medtronic | News | Comments

Medtronic, Inc. has announced the launch of the KYPHON Express II Balloon Kyphoplasty Platform, which includes the next generation KYPHON Cement Delivery System. This new platform is the latest advancement in the KYPHON Balloon Kyphoplasty...

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CE Mark for Boston Scientific's Deep Brain Stimulation System for Treating Tremor

September 17, 2014 9:17 am | by PR Newswire | News | Comments

Boston Scientific Corporation has received CE Mark for the Vercise Deep Brain Stimulation (DBS) System for the treatment of tremor, including the most common form of this movement disorder known as essential tremor (ET). Tremor is characterized...

Covidien Announces Start of Enrollment in Two Neurovascular Clinical Trials

September 16, 2014 10:11 am | by Covidien | News | Comments

Covidien plc announced today the start of enrollment in two clinical trials designed to further underscore the safety and effectiveness of the company’s advanced neurovascular solutions. Baptist Medical Center in Jacksonville, Florida, treated...

Medtronic Drug-Coated Balloon for Improved Treatment of Peripheral Artery Disease

September 16, 2014 9:55 am | by Medtronic | News | Comments

Presented for the first time at the 2014 Transcatheter Cardiovascular Therapeutics (TCT) conference, the latest clinical and economic data on the IN.PACT Admiral drug-coated balloon (DCB) from Medtronic, Inc. augments an already robust body of...

Type 2 Diabetes Patients Achieve Greater Satisfaction with Insulin Pumps vs. Multiple Daily Injections

September 16, 2014 9:44 am | by Medtronic | News | Comments

Medtronic, Inc. today announced that new results from the OpT2mise trial are being presented at the European Association for the Study of Diabetes (EASD) 50th Annual Meeting. OpT2mise is the largest global study to compare insulin pump therapy...

New York State a Beacon for Bio/Med Growth

September 16, 2014 9:13 am | by Jamie Leszczynski | News | Comments

The Bio/Med Breakthroughs: Advancing New York’s Innovation Economy industry report by MedTech, the trade association for bioscience and medical technology (Bio/Med) companies in New York, which was launched today at MEDTECH 2014, reveals a...

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Study Shows Abbott's Dissolving Heart Device Comparable to the World's Leading Heart Stent

September 15, 2014 10:49 am | by PR Newswire | News | Comments

Abbott announced today positive one-year clinical results from ABSORB II, the world's first prospective, randomized, controlled trial comparing the safety and effectiveness of the dissolving Absorb heart device to Abbott's market-leading metallic...

Medtronic Launches SEEQ Wearable Cardiac Monitoring System in United States

September 15, 2014 10:18 am | by Medtronic | News | Comments

Medtronic, Inc. has announced the U.S. launch of the SEEQ Mobile Cardiac Telemetry (MCT) System, an external, wire-free, adhesive heart monitor that can be worn for up to 30 days to help detect and diagnose the cause of irregular heartbeats in...

Medtronic’s CoreValve System Sustains Positive Outcomes Through Two Years in Extreme Risk Patients

September 15, 2014 10:14 am | by Medtronic | News | Comments

Medtronic, Inc. has announced new data showing that transcatheter aortic valve replacement (TAVR) with the CoreValve System continued to provide safe and effective treatment, while maintaining exceptional rates of survival out to two years for...

Philips Showcases Ultrasound Innovations that Address Clinical Challenges in the OB/GYN Segment

September 15, 2014 9:39 am | by The Associated Press | News | Comments

Royal Philips has announced that its growing range of advanced women's healthcare imaging solutions will be showcased at the 24th annual International Society for Ultrasound in Obstetrics and Gynecology (ISUOG) World Congress, taking place...

St. Jude Medical Announces Launch of OPTIS Integrated System

September 15, 2014 9:38 am | by The Associated Press | News | Comments

St. Jude Medical, Inc., a global medical device company, today announced the company has secured CE Mark and FDA clearance for the new OPTIS Integrated System. The system is a departure from traditional, mobile cart-based diagnostic tools...

IBA and Philips Join Forces to Advance Diagnosis and Treatment of Cancer

September 11, 2014 10:25 am | by LPP | News | Comments

IBA (Ion Beam Applications S.A.), the world’s leading provider of proton therapy and radiopharmacy solutions, and Royal Philips today announce the signing of a global collaboration to provide advanced diagnostic and therapeutic solutions for...

Medtronic NC Euphora Coronary Balloon Receives FDA Clearance

September 11, 2014 9:58 am | by Medtronic | News | Comments

Medtronic, Inc. today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of the NC Euphora Noncompliant Balloon Dilatation Catheter. The new device will be featured for the first time in the United States at the...

First U.S. Implants in Clinical Study of Medtronic’s Recapturable CoreValve Evolut R

September 10, 2014 9:39 am | by Medtronic | News | Comments

Medtronic, Inc. has announced the first U.S. implants in the CoreValve Evolut R Clinical Study, which will evaluate the safety and effectiveness of the new Medtronic CoreValve Evolut R System. This novel investigational self-expanding valve...

J&J's Ethicon Loses Another Mesh Trial

September 9, 2014 9:11 am | by PR Newswire | News | Comments

Legal-Bay LLC, The Lawsuit Settlement Funding Company, reported today that a Federal Jury in West Virginia awarded a husband and wife $3.27MM in damages, according to Bloomberg News, against Ethicon, Johnson & Johnson's mesh product division...

Olympus Launches New Hemostasis Clip with Advanced Control for GI Endoscopy

September 8, 2014 10:28 am | by PR Newswire | News | Comments

Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, announced today the commercial availability of its 510(k) cleared QuickClip Pro hemostasis...

New Technology May Uncover the Root of Critical Infections and Cut Healthcare Costs

September 8, 2014 10:19 am | by PR Newswire | News | Comments

A new study suggests a pioneering testing technology could reduce hospital stays by up to eight days and lower annual healthcare costs for people with serious infections by approximately $2.2 million. The cost reductions are based on a health...

FDA Approval of GE's SenoClaire - New Breast Imaging with 3D Tomosynthesis Solution

September 3, 2014 9:13 am | by The Associated Press | News | Comments

GE Healthcare has announced the FDA approval of SenoClaire, GE’s new breast tomosynthesis solution designed with a three-dimensional imaging technology. In collaboration with Massachusetts General Hospital, GE developed SenoClaire technology...

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